Skip to main content
OpenTrials
Completed

NCT Number: NCT04720976

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumor NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Phoenix, Arizona, United States

Loading trial locations.

About this study

To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated
  • Sufficient organ function
  • Participants must have at least 1 measurable lesion as defined by RECIST v1.1
  • Must be able to provide an archived tumor sample
  • ECOG performance status score of 0 or 1.

Exclusion criteria

  • History of cancer that is histologically distinct from the cancers under study
  • Active or untreated central nervous system (CNS) metastases
  • History of pneumonitis or interstitial lung disease (ILD)
  • Has active hepatitis B, hepatitis C infection, HIV
  • Any severe and/or uncontrolled medical conditions
  • LVEF ≤50%
  • QTcF >470 msec

Treatment and study plan

JAB-3312

Drug

JAB-3312 will be administered orally, variable dose.

Binimetinib

Drug

Binimetinib will be administered orally.

Pembrolizumab

Drug

Pembrolizumab will be administered as an intravenous infusion.

Sotorasib

Drug

Sotorasib will be administered orally.

Osimertinib

Drug

Osimertinib will be administered orally.

Primary outcomes

  1. Number of participants with dose limiting toxicities

    Time frame: 24 months

    Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

  2. Objective response rate (ORR)

    Time frame: 24 months

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)

  3. Duration of response (DOR)

    Time frame: 24 months

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)

  4. Duration of response (DCR)

    Time frame: 24 months

    DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)

  5. Progression-free survival (PFS)

    Time frame: 24 months

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)

  6. Overall survival (OS)

    Time frame: 24 months

    OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)

  7. Number of participants with adverse events

    Time frame: 24 months

    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: 24 months

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)

  2. Duration of response (DOR)

    Time frame: 24 months

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose escalation phase)

  3. Duration of response (DCR)

    Time frame: 24 months

    DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)

  4. Progression-free survival (PFS)

    Time frame: 24 months

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose escalation phase)

  5. Overall survival (OS)

    Time frame: 24 months

    OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)

  6. Plasma concentration (Cmax)

    Time frame: 24 months

    Highest observed plasma concentration of JAB-3312(dose escalation phase)

  7. Time to achieve Cmax (Tmax)

    Time frame: 24 months

    Time of highest observed plasma concentration of JAB-3312(dose escalation phase)

  8. Area under the plasma concentration-time curve (AUC)

    Time frame: 24 months

    Area under the plasma concentration time curve of JAB-3312(dose escalation phase)

  9. Number of participants with adverse events

    Time frame: 24 months

    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose expansion phase)

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Collaborators

  • AbbVie

Registry information

Official study title

A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.